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WO1999004848A1 - Aspiration arterielle - Google Patents

Aspiration arterielle Download PDF

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Publication number
WO1999004848A1
WO1999004848A1 PCT/US1998/015027 US9815027W WO9904848A1 WO 1999004848 A1 WO1999004848 A1 WO 1999004848A1 US 9815027 W US9815027 W US 9815027W WO 9904848 A1 WO9904848 A1 WO 9904848A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
aorta
outlet
balloon
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1998/015027
Other languages
English (en)
Inventor
Tracy D. Maahs
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Embol X Inc
Original Assignee
Embol X Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Embol X Inc filed Critical Embol X Inc
Priority to AU85023/98A priority Critical patent/AU8502398A/en
Publication of WO1999004848A1 publication Critical patent/WO1999004848A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12036—Type of occlusion partial occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Definitions

  • the present invention relates generally to devices for removing embolic material from blood vessels, and, more particularly, to an occlusion device (e.g., a balloon) for aspirating a blood vessel, such as the aorta during cardiac surgery, to remove embolic material from the vessel, and to methods of using such a device.
  • an occlusion device e.g., a balloon
  • a blood vessel such as the aorta during cardiac surgery
  • a cannula is typically introduced into the aorta to deliver blood from a bypass-oxygenator machine during cardiopulmonary bypass (CPB), as is used during coronary arterial bypass surgery and other procedures.
  • CPB cardiopulmonary bypass
  • Such a cannula generally includes a proximal end for receiving blood from the bypass-oxygenator machine, a distal end for entry into the artery, and a lumen extending between the proximal and distal ends.
  • calcified plaque or other embolic material may be dislodged during the procedure, particularly when clamping or unclamping the aorta. See Barbut et al. , "Cerebral Emboli Detected During Bypass Surgery Are Associated With Clamp Removal," Stroke, 25(12):2398-2402 (1994), incorporated herein by reference in its entirety, which quantifies the level of embolic release during each step of CPB and explains when protection from embolization is needed. Such embolic material may travel downstream, possibly becoming lodged in another portion of the blood vessel or possibly reaching a vital organ, such as the brain, where the material can cause substantial injury to the patient.
  • a blood filter device may be introduced into the blood vessel to capture any embolic material that becomes dislodged within the vessel.
  • a blood filter may be disposed on the distal end of an arterial cannula for capturing embolic material in the vessel into which the cannula is introduced.
  • Filters may have certain disadvantages because as blood flows through the filter, the blood may clot and attach to the filter mesh, possibly impairing flow through the filter, and consequently through the vessel.
  • the filter may become clogged with embolic material during use, preventing the device from effectively capturing additional material and/or impairing flow through the vessel.
  • the present invention is directed to a device for aspirating embolic material from a blood vessel, such as from the aorta during cardiac surgery, and also from the common carotid artery, external and internal carotid arteries, brachiocephalic trunk, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basilar artery, subclavian artery, brachial artery, axillary artery, iliac artery, renal artery, femoral artery, popliteal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, anterior tibial artery, posterior tibial artery and all other arteries carrying oxygenated blood.
  • the device is an arterial cannula with an occlusion device (e.g., a balloon occluder) capable of aspirating a blood vessel and thereby removing embolic material from the vessel.
  • the cannula is a substantially rigid elongate member having a proximal end adapted to receive blood from a bypass-oxygenator machine, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end.
  • the cannula has an aspiration port proximate to the outlet, which communicates with an aspiration lumen that extends proximally from the aspiration port along the cannula.
  • the cannula also includes an inflatable balloon attached to the cannula between the outlet and the aspiration port, the balloon being capable of assuming an inflated condition for occluding a blood vessel.
  • the distal end of the cannula is introduced into a blood vessel, such as into the ascending aorta upstream of the carotid arteries.
  • the outlet is oriented downstream for delivering blood into the vessel from a bypass- oxygenator machine.
  • the balloon on the cannula is then inflated to occlude the vessel, that is, the balloon expands and engages the wall of the vessel, thereby providing a fluid-tight seal between an upstream portion and a downstream portion of the vessel.
  • Fluid may then be introduced through the aspiration port into the upstream portion of the vessel, sweeping up loose embolic material within the upstream portion.
  • the fluid may then be withdrawn from the upstream portion of the vessel through the aspiration port, for example by connecting the aspiration lumen to hospital suction, thereby aspirating loose embolic material from the upstream portion of the vessel.
  • the device in a second preferred embodiment, includes an arterial cannula, a first balloon occluder attached to the cannula, and an aspiration port, similar to the embodiment described above.
  • the device also includes a second balloon occlusion device deployable from the distal end of the cannula, the second balloon also being capable of assuming an inflated condition for further occluding a blood vessel.
  • the second balloon is attached to the distal end of an elongate tubular member. The elongate tubular member is slidably received in the aspiration lumen, allowing the second balloon to slidably deployed from and retracted into the aspiration port.
  • a separate lumen may be provided in the cannula for the second balloon occlusion device.
  • the distal end of the cannula is introduced into a blood vessel, and the outlet is oriented downstream.
  • the first balloon is inflated to occlude the vessel, and substantially isolate an upstream portion of the vessel from a downstream portion.
  • the second balloon may then be deployed into the upstream portion of the vessel, for example into the aorta towards the coronary arteries.
  • the second balloon may then be inflated to further occlude the blood vessel, and substantially isolate the upstream portion, for example from the coronary arteries, to prevent fluid and/or embolic material from traveling upstream when the upstream portion is flushed.
  • Fluid may then be flushed into the vessel and aspirated out through the aspiration port as desired to remove loose embolic material from the upstream portion of the vessel.
  • the second balloon may then be deflated, and withdrawn back into the cannula.
  • the first balloon may be deflated, and the cannula removed from the vessel.
  • a device in accordance with the present invention allows a blood vessel to be dammed downstream from a location in which emboli are likely to be dislodged during the course of a surgical procedure.
  • the region of the vessel upstream of the dam may then be flushed and aspirated as desired, thereby removing embolic material released during the procedure and preventing the embolic material from escaping downstream and potentially injuring the patient.
  • an additional feature of a balloon occlusion device in accordance with the present invention is that the balloon may serve an additional function besides damming the vessel to allow loose embolic material to be aspirated away.
  • the balloon may substantially engage the walls of the vessel and provide a fluid- tight seal, thereby eliminating the need for other devices to block the vessel, such as a cross clamp which is often used to clamp the aorta during cardiac surgery.
  • FIG. 1 is a cross-sectional view of a cannula with balloon occluder in accordance with the present invention introduced into the ascending aorta of a patient.
  • FIG. 2 is a cross-sectional detail of the cannula of FIG. 1 with the balloon inflated to occlude a blood vessel.
  • FIG. 3 is a cross-sectional view of another embodiment, including a second balloon occluder introduced into the ascending aorta.
  • FIGS. 1 and 2 show a preferred embodiment of a device 10 for aspirating embolic material from a blood vessel.
  • the device 10 includes an aortic cannula 20, a balloon occluder or dam 40 and an aspiration port 50.
  • the cannula 20 is an elongate tubular member 22, having a proximal end (not shown), a distal end 24, and a lumen 26 which extends between the proximal and distal ends 24.
  • the proximal end is adapted for receiving blood from a bypass-oxygenator machine (not shown).
  • the distal end 24 has a tapered, curved and/or rounded end adapted to enter an artery, and includes an outlet 28 communicating with the lumen 26.
  • the cannula 20 is generally formed from a substantially rigid material, such as conventional medically suitable plastic or rubber materials, appropriate for aortic cannulation devices.
  • the distal end 24 preferably also includes a curved or lateral outlet portion 30 that extends substantially perpendicularly to the longitudinal axis of the elongate tubular member 22 and has the outlet 28 thereon.
  • the proximal edge 32 of the outlet portion 30 is preferably rounded and/or curved to facilitate introduction into a blood vessel.
  • the outlet portion 30 also includes a curved lumen 36 extending between the lumen 26 in the cannula 20 and the outlet 28, the lumen 36 preferably being radiused to minimize the risk of hemolysis or other problems which may be caused by an abrupt change in direction of blood flow.
  • the balloon occluder 40 is an inflatable balloon 42 attached to the cannula 20, preferably to the outer surface 34 of the outlet portion 30 adjacent to the outlet 28.
  • the balloon 42 has an annular shape capable of assuming an inflated condition for occluding or damming a blood vessel into which the device 10 is introduced.
  • the inflatable space 44 within the balloon 42 communicates with an inflation lumen (not shown) that extends proximally along the cannula 20 towards the proximal end thereof.
  • a source of inflation media (not shown), such as saline, may be directed into and out of the inflation lumen, preferably from the proximal end of the cannula 20 to inflate and deflate the balloon 42.
  • the cannula 20 also includes an aspiration port 50, preferably adjacent the proximal edge 32 of the outlet portion 30.
  • the aspiration port 50 communicates with an aspiration lumen 52 for aspirating and/or flushing the vessel.
  • the aspiration lumen 52 extends proximally along the cannula 20 towards the proximal end thereof.
  • a source of fluid for flushing the vessel such as saline, and a source of vacuum, such as hospital suction, may be switchably connected to the aspiration lumen 52, preferably at the proximal end of the cannula 20.
  • a separate lumen (not shown) for introducing fluid into the vessel may be provided in addition to the aspiration lumen 52.
  • each of the lumens that is, the blood flow lumen 26, the aspiration lumen 52 and the inflation lumen (not shown) are substantially isolated from one another throughout their lengths.
  • the aspiration port 50 is located proximal of the outlet 28, and the balloon occluder 40 is mounted between the aspiration port 50 and the outlet 28.
  • the distal end 24 of the cannula 20 may be oriented within a blood vessel such that the outlet 28 is directed in a downstream direction, and the aspiration port 50 is located upstream of the outlet 28. As shown in FIGS.
  • the device 10 may be particularly useful for aspirating a vessel such as the aorta 90, that is, for removing embolic material from the ascending aorta 92, to prevent embolic material from traveling downstream, especially into the carotid arteries 94 and possibly to the brain (not shown) where embolic material may cause substantial damage.
  • the distal end 24 of the cannula 20 is introduced into the vessel 90 using conventional procedures providing thorascopic access to the vessel. For example, a thoracotomy may be performed to create a passage into the patient's chest and into the vessel, through which the cannula 20 may be introduced.
  • the outlet 28 is directed downstream to allow blood to be delivered through the blood flow lumen 26 into the vessel 90 from a bypass-oxygenator machine (not shown).
  • the balloon 42 is inflated until the outer periphery 46 of the balloon 42 substantially engages the wall 96 of the vessel 90, thereby providing a fluid-tight seal and damming the lumen 98 of the vessel 90.
  • the inflated balloon 42 may provide a sufficient seal, for example, such that the balloon 42 may be used instead of a cross clamp to clamp the aorta 90 during a coronary bypass procedure.
  • a cross clamp 100 may be provided to clamp the aorta 90, as described below.
  • the inflated balloon 42 divides the lumen 98 of the vessel 90 into an upstream portion 98a and a downstream portion 98b that are substantially isolated from one another. If a separate clamp 100 is used, the ascending aorta 92 may then be clamped upstream of the balloon 42 in preparation for cardiac surgery, possibly dislodging embolic material from the wall 96. Any material released will be retained in the upstream portion 98a of the aorta 90, unable to travel downstream because of the inflated balloon 42.
  • fluid such as saline
  • fluid may be introduced through the aspiration port 50 into the upstream portion 98a, for example, from a source attached to the aspiration lumen 52 at the proximal end of the cannula 20.
  • the fluid may enter the upstream portion 98a and flush any loose embolic material therein.
  • Suction may then be provided through the aspiration lumen 52, removing the fluid and loose embolic material from the upstream portion 98a, into the aspiration port 50 and out the aspiration lumen 52.
  • the process of flushing and aspirating the upstream portion 98a of the aorta 90 may be repeated as often as desired during the procedure to remove loose embolic material therein and/or to dislodge additional embolic material, for example which may be caught between the balloon 42 and the wall 96 of the vessel 90.
  • embolic material may be released when the aorta is clamped and undamped, or when the heart and/or aorta are manipulated.
  • the device 10 allows the upstream portion 98a to be flushed and aspirated as often as desired before the end of the procedure, without concerns about impairing flow through the vessel 90 as may occur when a blood filter device is used.
  • the balloon 42 may then be deflated, allowing resumed blood flow through the vessel 90, and the cannula 20 may then be removed using conventional procedures.
  • FIG. 3 a second embodiment of a device 10 in accordance with the present invention is shown.
  • the device 10 includes an arterial cannula 20, a first balloon occluder 40 and an aspiration port 50.
  • the device 10 includes a second balloon occlusion device 60.
  • the occlusion device 60 is provided as part of and is deliverable from the cannula 20, although alternatively the occlusion 60 may be deployed from a separate cannula (not shown) that may be introduced into the vessel upstream of the by-pass cannula 20.
  • the occlusion device 60 includes an elongate tubular member 62 and a second balloon occluder 70.
  • the tubular member 62 has a proximal end (not shown), a distal end 66, and preferably includes a lumen 64 extending between the proximal end (not shown) and the distal end 66, for example for providing a cardioplegia port for cardiac procedures.
  • the tubular member 62 may be formed from a semi-rigid and/or resilient material, such as plastic or metal, that facilitate introduction of the occlusion device 60 into the vessel 90.
  • the second balloon occluder 70 similar to the first balloon occluder
  • the 40 includes an inflatable balloon 72 capable of assuming an inflated condition for damming the lumen of a vessel.
  • the second balloon 72 has an annular shape, and is attached to the outer surface 68 of the tubular member 62 adjacent the distal end 66 thereof.
  • the inflatable space 74 within the balloon 72 communicates with an inflation lumen (not shown) that preferably extends proximally along the tubular member 62 to a conventional source of an inflation media, for example on the proximal end of the tubular member 62.
  • the second occlusion device 60 is generally slidably received in the cannula 20.
  • the distal end 66 of the tubular member 62 is inserted into the aspiration lumen 52 at the proximal end of the cannula 20 and directed distally until it reaches the aspiration port 50.
  • the tubular member 62 may have a diameter substantially smaller than the aspiration lumen 52, thereby allowing fluid to be flushed and aspirated through the lumen 52, even with the tubular member 62 extending therethrough.
  • the cannula 20 may include a separate lumen (not shown) for the second occlusion device 60.
  • the second occlusion device 60 may be deployed into the vessel to further dam the vessel.
  • the second occlusion device 60 may be particularly useful in a cardiac surgical procedure for removing loose embolic material within the aorta.
  • the cannula 20 is introduced into a vessel 90, such as the ascending aorta 92, with the outlet 28 directed downstream, for delivery of blood into the vessel 90 from a bypass- oxygenator machine, similar to the embodiment described above.
  • the first balloon 42 is inflated to dam the vessel 90, and provide a substantially fluid-tight seal between the upstream portion 98a of the vessel 90 and the downstream portion 98b into which the blood is delivered.
  • the second occlusion device 60 may then be introduced into the upstream portion 98a, for example towards the coronary arteries 99.
  • the second balloon 72 may be inflated to dam the vessel 90 further, for example, to seal the upstream portion 98a from the coronary arteries 99.
  • fluid may be flushed into the upstream portion 98a of the vessel 90 from the aspiration port 50 for removing embolic material.
  • the second balloon occluder 70 prevents the fluid, and consequently any embolic material, from entering the coronary arteries 99.
  • the fluid may be suctioned from the upstream portion 98a into the aspiration lumen 50, removing loose embolic material.
  • the second balloon 72 may be deflated, and the occlusion device 60 may be withdrawn back into the aspiration lumen 52.
  • fluid may be flushed into and/or aspirated from the upstream portion 98a subsequent to deflation of the second balloon 72, to remove additional embolic material that may be dislodged during deflation.
  • the first balloon 42 may then be deflated, and the cannula 20 removed from the vessel 90.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)

Abstract

Cette invention se rapporte à un dispositif d'occlusion à ballonnet (10) servant à aspirer une formation embolique d'un vaisseau sanguin, tel que l'aorte, lors d'une intervention cardiaque. Ce dispositif (10) comprend une canule artérielle (20) comportant une extrémité proximale destinée à recevoir le sang provenant d'un oxygénateur à circulation extracorporelle, et une extrémité distale (24) destinée à pénétrer dans une artère, ainsi qu'un passage (26) d'écoulement du sang, s'étendant entre l'extrémité proximale et une sortie (28) de l'extrémité distale (24). La canule (20) présente un orifice d'aspiration (50) proche de la sortie (28), qui communique avec un passage d'aspiration (52). La canule (20) comprend également un ballonnet gonflable (42) fixé à la canule (20) entre la sortie (28) et l'orifice d'aspiration (50), et elle peut se gonfler pour boucher un vaisseau sanguin. Lors de l'utilisation de ce dispositif (10), l'extrémité distale (24) de la canule (20) est introduite dans un vaisseau sanguin, tel que l'aorte. La sortie (28) est orientée en aval pour laisser passer le sang et le ballonnet (42) est gonflé de façon à boucher les vaisseaux. Un fluide peut ensuite être chassé dans le vaisseau et aspiré hors du vaisseau à travers l'orifice d'aspiration (50), selon les besoins, pour retirer la formation embolique qui s'est détachée du vaisseau en amont du ballonnet (42). Le dispositif (10) peut éventuellement comporter un second ballonnet déployé (70) destiné à boucher le vaisseau en un second point.
PCT/US1998/015027 1997-07-24 1998-07-21 Aspiration arterielle Ceased WO1999004848A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU85023/98A AU8502398A (en) 1997-07-24 1998-07-21 Arterial aspiration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/899,606 US5928192A (en) 1997-07-24 1997-07-24 Arterial aspiration
US08/899,606 1997-07-24

Publications (1)

Publication Number Publication Date
WO1999004848A1 true WO1999004848A1 (fr) 1999-02-04

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/015027 Ceased WO1999004848A1 (fr) 1997-07-24 1998-07-21 Aspiration arterielle

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US (3) US5928192A (fr)
AU (1) AU8502398A (fr)
WO (1) WO1999004848A1 (fr)

Cited By (8)

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WO2000054829A3 (fr) * 1999-03-16 2001-01-11 Chase Medical Inc Catheter comportant un ballonnet a resilience variable
US6210363B1 (en) 1999-02-23 2001-04-03 Cardeon Corporation Methods and devices for occluding a vessel and performing differential perfusion
US6319244B2 (en) 1999-03-16 2001-11-20 Chase Medical, L.P. Catheter with flexible and rigid reinforcements
US6508777B1 (en) 1998-05-08 2003-01-21 Cardeon Corporation Circulatory support system and method of use for isolated segmental perfusion
US6527791B2 (en) 1999-10-25 2003-03-04 John S. Fisher Emboli capturing device
US6726651B1 (en) 1999-08-04 2004-04-27 Cardeon Corporation Method and apparatus for differentially perfusing a patient during cardiopulmonary bypass
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US6196994B1 (en) 2001-03-06
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US6689149B2 (en) 2004-02-10
US5928192A (en) 1999-07-27

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